ASN: ESA Protocol Reduces Exposure, Preserves Hemoglobin

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that dialysis patients had less exposure to epoetin alfa with no deterioration of hemoglobin values when they were switched from an intravenous to a subcutaneous protocol.

DENVER -- Dialysis patients had less exposure to epoetin alfa with no deterioration of hemoglobin values when they were switched from an intravenous to a subcutaneous protocol, according to a study reported here.

Monthly epoetin alfa use declined by 15.7% following implementation of a subcutaneous protocol. Two-thirds of the patients maintained hemoglobin values within the target range after the transition, Neeta O'Mara, PharmD, reported at the American Society of Nephrology meeting.

"We have demonstrated the feasibility, efficacy, and safety of switching from an intravenous to a subcutaneous protocol for administration of epoetin alfa," said O'Mara, of Dialysis Clinic Inc. (DCI) in New Brunswick, N.J. "In general, the subcutaneous protocol was well tolerated and accepted by the patients."

"Conversion to subcutaneous epoetin alfa was associated with a reduction in the number of doses administered, the supplies used, and in nursing time associated with administration," she added.

In 2007 the FDA issued a warning related to exposure to erythropoiesis-stimulating agents, following reports that suggested an increased mortality risk in patients with kidney disease treated with the agents. In response to the warning, DCI lowered its target hemoglobin level from 11 to 13 g/dL to 10 to 12 g/dL.

To reduce ESA exposure even further, the three DCI facilities in New Jersey developed a subcutaneous epoetin alfa protocol, which was implemented during April and May of 2009.

Prior to the transition, patients received intravenous epoetin alfa three times a week during dialysis sessions. Initially, the three intravenous doses were replaced by three subcutaneous doses, which ranged from 66% to 125% of the last intravenous dose of epoetin alfa, depending on baseline hemoglobin.

The three subcutaneous doses of the ESA were then reduced to a single dose as quickly as possible, said O'Mara.

The study of the transition in dosing included 160 patients, mean age 66, from the three New Jersey DCI facilities. The patients had been on dialysis for a mean of 5.5 years.

The final analysis comprised the last three months of intravenous dosing, the first three months of subcutaneous dosing, and months seven through nine after the transition.

During the last three months of the IV protocol, 63.7% of patients remained within the target hemoglobin range of 10 to 12 g/dL.

During the first three months of the conversion to subcutaneous dosing, the proportion of patients with hemoglobin in the target range dipped slightly to 61.3% before increasing to 66.3% by ninth month.

O'Mara reported that the total monthly units of epoetin alfa decreased from almost 32.5 million at the end of the IV period to less than 27.4 million by the ninth month of implementation of the subcutaneous protocol. The number of units per kilogram of body weight declined from 443,392 to 372,577 (a 16% difference).

The total number of doses administered per month decreased by 54%, from 5,152 to 2,393.

The number of patients on once-weekly dosing increased from 14 to 121, and the number receiving three doses a week decreased from 144 to 16.

Before the conversion, 5% of the patients had hemoglobin values <10 g/dL, increasing to 15% after nine months on the subcutaneous protocol. The proportion of patients with hemoglobin levels >12 g/dL decreased from 31.3% to 18.7%.

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